OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I

{0}------------------------------------------------ # PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.92) ### 807.92 (a): | 1. Submitter's Name: | OraSure Technologies, Inc. | |----------------------|--------------------------------------| | Address: | 150 Webster St., Bethlehem, PA 18015 | | Telephone Number: | (610) 882-1820 | | Contact Person: | R. Sain Niedbala, Ph.D., BCFE | | Date Prepared: | April 10, 2002 | - 2. Device Name: Benzodiazepines Intercept® MICRO-PLATE EIA Proprietary Name: Benzodiazepines Intercept® System Usual Name: Enzyme Immunoassay, Benzodiazepine Classification Name: Device to Which Substantial Equivalence Is Claimed: 3. - Roche Diagnostic Systems, Abuscreen ONLINE® kit for Benzodiazepines (urine); K914509 - Description of Device: 4. #### Principle of the Assay The OT1 Benzodiazepines Intercept® MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an ELA well containing an oral fluid specimen positive for benzodiazepines, there is a competition between the drug and the enzymelabeled hapten to bind the antibody fixed onto the EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 mm is inversely proportional to the amount of benzodiazepines present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for benzodiazepines testing using oral fluid, OTI recommends a cutoff of 1.0 ng/mL when testing oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. This cutoff is within the limit of detection by the OTI Benzodiazepines Intercept® MICRO-PLATE EIA. #### న్. Intended Use Statement: The OTI Benzodiazepines Intercept® MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device using a 1.0 ng/mL(nordiazepine) cutoff. For In Vitro Diagnostic Use. The OTI Benzodiazepines Intercept® MICRO-PLATE EIA provides only a preliminary analytical test result. A more specific alternative chemical method should be used in order to obtain a Gas chromatography/mass spectrometry/mass spectrometry confirmed analytical result. (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when a preliminary, positive result is observed. #### a. Summary of Technological Characteristics: 6. The OTI Benzodiazenines Intercept® MICRO-PLATE EIA is based on the principle of solid phase competitive enzyme immunoassay. This application is for the OTI Benzodiazepines EIA as a screening tool for the detection of benzodiazepines using specimens collected with the OTIIntercept& Oral Fluid Drug Test Oral Specimen Collection Device. {1}------------------------------------------------ ## b. Summary of Performance Data: and the state of the state of the states of the states The performance characteristics of the OTI Benzodiazepines Intercept® MICRO-PLATE EIA are summarized below. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device. | | Proposed: | | | | | | | Previously | |------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------|-----------------------|------------------|------|----------------|-----------------| | | Benzodiazepines Intercept® | | | | | | | Cleared | | | MICRO-PLATE EIA | | | | | | | (K914509): | | | | | | | | | | Abuscreen | | | | | | | | | | ONLINE® kit for | | | | | | | | | | Benzodiazepines | | Performance Characteristics: | | | | | | | | | | Precision | | | | | | | | | | Intra-assay %CV range | 4.9-6.5% | | | | | | | 2-7% | | Inter-assay %CV range | 7.6-11.4% | | | | | | | 2-10% | | Limit of Detection | 0.2 ng/mL | | | | | | | < 10 ng/mL | | % Cross-Reactivity | | | | | | | | | | α-Hydroxyalprazolam | 10% | | | | | | | 112% | | α-Hydroxytriazolam | 15% | | | | | | | 98% | | Alprazolam | 151% | | | | | | | 96% | | 7-Aminoflunitrazepam | 6% | | | | | | | Not tested | | 7-Aminonitrazepam | 8% | | | | | | | 52% | | Bromazepam | 2% | | | | | | | 75% | | Clorazepate | 70% | | | | | | | 43% | | Chlordiazepoxide | 6% | | | | | | | 55% | | Clonazepam | 1% | | | | | | | 56% | | Desalkylflurazepam | 17% | | | | | | | 49% | | Diazepam | 135% | | | | | | | 105% | | Estazolam | 130% | | | | | | | Not tested | | Flurazepam | 49% | | | | | | | 61% | | 2-Hydroxyethylflurazepam | 8% | | | | | | | 88% | | Lorazepam | < 1% | | | | | | | 59% | | Medazepam | 17% | | | | | | | 40% | | Midazolam | 49% | | | | | | | 96% | | Nitrazepam | 39% | | | | | | | 81% | | Norchlordiazepoxide | 3% | | | | | | | Not tested | | Oxaprozin | <1% | | | | | | | Not tested | | Oxazepam | 7% | | | | | | | 98% | | Prazepam | 107% | | | | | | | 84% | | Temazepam | 55% | | | | | | | Not tested | | Triazolam | 26% | | | | | | | 96% | | Clinical Accuracy | Three separate population studies were performed to | | | | | | N=50 confirmed | | | | characterize performance of the Intercept Test. A total of | | | | | | positive. | | | | 149 specimens were collected from all three populations. | | | | | | 42 positive, 8 | | | | | | | | | | negative | | | | | | | | | | | | | | The table below summarizes the performance of the<br>Intercept kit with all specimens tested by immunoassay | | | | | | | | | | and GC/MS/MS. | | | | | | | | | | Intercept<br>Result | No Drug<br>Detected<br>by<br>GC/MS/MS | 0.18-0.49 | 0.5-<br>0.99ng<br>/mL | 1.0-<br>1.5ng/mL | >1.5 | | | | | Positive | 4 | 5 | 1 | 2 | 26 | | | | | Negative | 93 | 7 | 3 | 4 | 4 | | | | | | | | | | | | | 12 ं · {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or flowing lines. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 R. Sam Niedbala, Ph.D., BCFE Chief Science Officer OraSure Technologies, Inc. 150 Webster Street Bethlehem, PA 18015 # APR 1 7 2002 Re: k013882 Trade/Device Name: OTI BENZODIAZEPINES INTERCEPT® MICRO-PLATE EIA Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: March 12, 2002 Received: March 14, 2002 ### Dear Dr. Niedbala: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ## Page 2 - This letter will allow you to begin marketing your device as described in your 510(k) premarket This leater will and in your distantial equivalence of your device to a legally marketed nothloation: "The results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 II you desire specific and in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 591 1500 - 11 deather (1) entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miountacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: OTI BENZODIAZEPINES INTERCEPT® MICRO-PLATE EIA Indications For Use: The OTI Benzodiazepines Intercept® MICRO-PLATE EIA is intended for use by clinical I he off Donazonalespines determination of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device using a 1.0 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE. The OTI Benzodiazepines Intercept® MICRO-PLATE EIA provides only a preliminary I ne OTF betwould. A more specific alternative chemical method should be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry/mass spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when a preliminary, positive result is observed. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------------| | (Division Sign-Off) | Von Dr Cooper | | Division of Clinical Laboratory Devices | | | 510(k) Number | K013882 | | Prescription Use (Per 21 CFR 801.109) | | OR Over-The-Counter Use ________ c:\fda\indica.doc . . . . c:\fda\indica.doc